WO2016187568A1 - Surveillance d'événements d'incontinence - Google Patents

Surveillance d'événements d'incontinence Download PDF

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Publication number
WO2016187568A1
WO2016187568A1 PCT/US2016/033590 US2016033590W WO2016187568A1 WO 2016187568 A1 WO2016187568 A1 WO 2016187568A1 US 2016033590 W US2016033590 W US 2016033590W WO 2016187568 A1 WO2016187568 A1 WO 2016187568A1
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WO
WIPO (PCT)
Prior art keywords
reader
caregiver
resident
tag
reading
Prior art date
Application number
PCT/US2016/033590
Other languages
English (en)
Inventor
Carolyn Reeder MACNAUGHTON
Robert Malcolm David MACNAUGHTON
Original Assignee
Wave Sensor, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Wave Sensor, Inc. filed Critical Wave Sensor, Inc.
Priority to US15/572,154 priority Critical patent/US11173073B2/en
Publication of WO2016187568A1 publication Critical patent/WO2016187568A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • GPHYSICS
    • G08SIGNALLING
    • G08BSIGNALLING OR CALLING SYSTEMS; ORDER TELEGRAPHS; ALARM SYSTEMS
    • G08B21/00Alarms responsive to a single specified undesired or abnormal condition and not otherwise provided for
    • G08B21/18Status alarms
    • G08B21/20Status alarms responsive to moisture
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/15Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/42Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm
    • A61F2013/424Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators with wetness indicator or alarm having an electronic device

Definitions

  • incontinence is projected to increase as the baby boomer population ages.
  • the US population has aged dramatically.
  • the U.S. population as a whole has doubled, yet the number of Americans aged 60 or more has increased tenfold. It is also estimated that between 15-30% of Americans aged 60 or more have or will suffer from incontinence. Thus, the challenges created by incontinence will continue to escalate.
  • Incontinence also tends to affect women disproportionately more than men. In fact, 16% of all women experience incontinence by age 75.
  • LTC long-term care
  • LTC service providers include adult living facilities (ALFs), adult day services centers, skilled nursing facilities (SNFs) and similar residential care communities, home health agencies, and hospices; currently accounting for an estimated 5.3M incontinent residents.
  • ALFs adult living facilities
  • SNFs skilled nursing facilities
  • the condition is among the most prevalent reasons why seniors are admitted to SNFs and ALFs. It is believed that approximately 50% of all LTC facility admissions are tied to injuries/symptoms related to incontinence. Commensurately, it is estimated that up to 50% of all LTC facility residents suffer from incontinence.
  • incontinence detection devices are not widely available.
  • the most common detection device used in the facility environment is the "blue-stripe" indicator brief.
  • Such briefs use chemical detection means to show a blue stripe when the brief is wet.
  • this solution still requires the caregiver to disturb the patient/resident in order to view the visible stripe. For example, the caregiver would still need to disrobe the patient/resident at night and use a light in order to check the wetness indicator.
  • Incontinence affects a large and growing population. It is time consuming and difficult for patient and caregiver to manage well. Yet, if not managed well, there are severe and costly health risks. Accordingly, there is ample opportunity to address the health concerns of incontinence.
  • RFID tags are inexpensive, disposable, have indefinite shelf life, and do not require battery power at the source of the sensor.
  • an RFID tag including an integrated circuit is affixed to an incontinence brief and a handheld RFID reader to detect when a resident has voided and has a wet brief.
  • moisture comes close to the specifically designed RFID tag antenna and "detunes" the tag by altering the permittivity of at least a portion of the area surrounding the antenna.
  • the RFID tag detects a shift in a signal received from a querying RFID reader (e.g. , a shift in frequency), encodes the level of detuning detected, and transmits a signal back to the RFID reader indicating a level of detuning measured.
  • a querying RFID reader e.g. , a shift in frequency
  • the RFID reader is a wearable mobile device that can be carried by a caregiver. When within proximity (e.g., 3-4 feet) of a patient/resident, the caregiver can use the RFID reader to check on the status of the tag affixed to the resident's brief.
  • the RFID reader can be, but is not limited to, a smartphone enabled handheld reader, a Microsoft CE based handheld reader, a Motorola handheld reader, and/or a fixed reader.
  • FIG. 1 illustrates a system including an incontinence brief that is attached to a passive RFID assembly and an RFID reader, as can be used in certain examples of the disclosed technology.
  • FIG. 2 illustrates a smart phone device coupled to a RFID reader assembly and an RFID tag, as can be used in certain examples of the disclosed technology.
  • FIG. 3 illustrates an example of an RFID reader signaling to, and receiving data from,an RFID tag assembly.
  • FIG. 4 is a block diagram illustrating a number of components that can be used for monitoring incontinence events according to certain examples of the disclosed technology.
  • FIG. 5 illustrates a suitable computing environment in which certain examples of the disclosed technology can be implemented.
  • FIG. 6 is a plan view of two RFID antenna assemblies that can be used in certain examples of the disclosed technology.
  • FIG. 7 is a photograph of a number of suitable RFID assemblies that can be used to implement certain examples of the disclosed technology.
  • FIG. 8 is a photograph of a mobile device coupled to an RFID reader that can be used in certain examples of the disclosed technology.
  • FIG. 9 is a photograph of a number of incontinence garments coupled to an RFID antenna and a smart device, as can be used in certain examples of the disclosed technology.
  • FIG. 10 is a flowchart outlining an example method of processing sensor data received from a garment.
  • FIG. 11 is a flowchart outlining an example method of evaluating a sensor condition, as can be used in certain examples of the disclosed technology.
  • FIG. 12 is a table outlining data that can be output using certain examples of the disclosed technology.
  • Any of the disclosed methods can be implemented as computer-executable instructions stored on one or more computer-readable media (e.g. , non-transitory computer-readable media, such as one or more optical media discs, volatile memory components (such as DRAM or SRAM), or nonvolatile memory components (such as hard drives)) and executed on a computer (e.g. , any commercially available computer, including smart phones or other mobile devices that include computing hardware).
  • a computer e.g. , any commercially available computer, including smart phones or other mobile devices that include computing hardware.
  • Any of the computer-executable instructions for implementing the disclosed techniques, as well as any data created and used during implementation of the disclosed embodiments can be stored on one or more computer-readable media (e.g. , non- transitory computer-readable media).
  • the computer-executable instructions can be part of, for example, a dedicated software application, or a software application that is accessed or downloaded via a web browser or other software application (such as a remote computing application).
  • Such software can be executed, for example, on a single local computer (e.g., as an agent executing on any suitable commercially available computer) or in a network environment (e.g., via the Internet, a wide-area network, a local-area network, a client-server network (such as a cloud computing network), or other such network) using one or more network computers.
  • any of the software-based embodiments (comprising, for example, computer-executable instructions for causing a computer to perform any of the disclosed methods) can be uploaded, downloaded, or remotely accessed through a suitable communication means.
  • suitable communication means include, for example, the Internet, the World Wide Web, an intranet, software applications, cable (including fiber optic cable), magnetic communications, electromagnetic communications (including RF, microwave, and infrared communications), electronic communications, or other such communication means.
  • FIG. 1 is a diagram of a system that can be used for monitoring incontinence events.
  • an incontinence brief 100 worn by an individual includes a passive RFID assembly 120 attached to the brief.
  • the passive RFID tag assembly 120 includes an antenna and an integrated circuit.
  • the integrated circuit will receive a radio signal 130 transmitted by a reader assembly 140 to the RFID tag assembly 120.
  • the reader assembly 140 includes a smartphone device 145 coupled to an RFID transceiver 147. Based on changes in the electric field near the passive RFID tag due to changes in moisture, for example, caused by an incontinence event, the passive RFID assembly 120 detects "detuning" of the signal 130 received from the reader assembly 140.
  • the integrated circuit determines a detuning level and encodes this level as data in a radio signal 150 that is transmitted back to the reader assembly 140.
  • the reader assembly 140 includes a smartphone device 145 coupled to an RFID transceiver 147.
  • a transceiver is incorporated within the smartphone itself.
  • the passive RFID tag assembly 120 is desirably inexpensive and disposable and can be affixed to the brief when installed on a patient using, for example, an adhesive. In some examples the adhesive is included with the RFID tag assembly 120, such as in a disposable bandage. Because the RFID tag assembly 120 includes a sensor that can detect changes in the signal received from the RFID transceiver 147, accuracy of moisture levels in the incontinence garment can be substantially increased.
  • the chronically incontinent individual typically wears an incontinence brief (adult diaper) to manage his/her condition.
  • Many individuals who wear incontinence briefs require help from a caregiver to check his/her briefs for the presence of an incontinence event as well as help changing the brief when it has been soiled.
  • a user affixes an RFID tag to the individual' s incontinence brief.
  • the tags have adhesive on one side, and gauze on the other.
  • the form factor resembles an adhesive bandage. The backing is removed and an adhesive allows the tag to be placed on the exterior of the brief in the approximate location where a brief will fill with evacuated urine.
  • the tag could be manufactured into the interior of the brief for optimal placement (removes caregiver judgment on placement).
  • the tag could also be designed to be placed on the interior of the brief.
  • the tag can be used with any incontinence brief. It is small and unobtrusive to the individual wearing the brief. The individual puts clothes on and resumes daily activities with the apparatus ready for use.
  • the caregiver carries a mobile RFID reader (an example of a reader assembly) with him/her.
  • the caregiver wants to check the condition of an individual's brief (e.g., if it is wet or dry)
  • the caregiver aims the reader antenna in the direction of the individual wearing the RFID tag.
  • a direct "line of sight" is needed; however, a reading can be taken through clothing, blankets, etc.
  • the caregiver then pushes the start button on the reader to have the reader send a RFID signal to the passive tag.
  • the reading returned gives an indication of whether the antenna is being or has been detuned.
  • the software on the reader interprets this signal for the caregiver to indicate a wet vs dry condition of the brief.
  • the caregiver knows if a brief change is needed and will take the appropriate action. Since the disclosed technology will work through blankets and clothing, minimal disruption is needed for the individual.
  • the reader records the check that was made. Since the handheld reader is directional and a relatively short distance is needed between the tag and reader (2-4 feet), the caregiver can use the reader software to indicate which resident is being scanned and the physical action that was taken for that individual (e.g., was a change made or not). Alternatively a unique identifying code could be encoded on the tag IC to indicate which tag is being read. This data and action recorded can be kept as charting data for the individual patient's care. This data can also be used for management reporting and quality oversight.
  • FIG. 2 illustrates an RFID reader assembly 200, as can be implemented in some examples of the disclosed technology.
  • the reader assembly 200 includes a smartphone device 210 which includes a graphical user interface implemented with a touch screen display 215, and is coupled to an RFID reader 220.
  • the RFID reader includes an antenna and a battery 227, which can be used to extend the life of operation of the smartphone device by not drawing power in order to generate RFID signals.
  • the smartphone can include a touchscreen display, voice recognition, and/or gesture- sensing technologies to enable a user, e.g. , a caregiver, to interact and view alerts generated responsive to the RFID tag attached to the patient's garment. Also shown in FIG.
  • the illustrated system provides an economical system for detecting moisture events in an incontinence garment, without requiring physical inspection of the patient's garment.
  • FIG. 3 illustrates an electromagnetic signal 300 being transmitted from the RFID reader 220 to an RFID tag assembly 230, which transmits a signal 310 back to the reader assembly, as can be performed in some examples of the disclosed technology.
  • the reader In some examples of the disclosed technology, commercially available handheld RFID readers are used. The caregiver carries the handheld reader with them, and can check on the brief status of the resident at his/her discretion or according to protocol. At this time, the reader is directional, meaning that the reader' s antenna needs to be pointed towards the tag it is reading. Currently the readers used can obtain 2-3 feet of read range. This can be enhanced with power output from the reader; however increased power output is directly related to battery life so given current options, a balance is needed. In the current format, slight software modifications are needed for the reader to be able to read the sensor code returned from the IC. [041] In some examples of the disclosed technology, the reader connects to a smartphone and is enabled through an application on the smartphone.
  • the smartphone has a custom-built app for it and this is the user interface the caregiver experiences. All data collected through the readings can then be stored, compiled and transferred.
  • the smartphone uses all the power available through a smartphone reader. As RFID capability is built into smart devices, there may be a time this additional connection is not necessary.
  • the reader uses a Windows CE platform and Bluetooth technology to compile and transfer data.
  • a fixed RFID reader could be used. These are more powerful as they can connect directly to a plug in the wall, but also are less mobile and more costly at this time. Since the reader needs a line of sight to the tag, the fixed reader is also less flexible for its reading. Yet as reader technology improves, a fixed reader could be constantly monitoring a part of the resident's room such as the doorway, a chair commonly used, or the bed.
  • FIG. 4 is a block diagram 400 that illustrates a number of components as can be used in some examples of monitoring incontinence events according to the disclosed technology.
  • an integrated circuit 410 includes memory 420, a wireless communication engine 421, and a sensor engine 422.
  • the integrated circuit 410 is electrically connected to an antenna 430.
  • the integrated circuit 410 and antenna 430 can be combined into an inlay assembly 440 for convenient use and disposal.
  • the inlay assembly 440 can be produced as a roll of devices, such that a caregiver can detach and attach a single inlay assembly to a garment 450.
  • the inlay assembly 440 can be included with a disposable incontinence garment during manufacture of the garment 450.
  • the assembly is desirably situated near a region of the incontinence garment where liquid resulting from a void event are likely.
  • the position of the inlay assembly can be altered for a male patient versus a female patient.
  • a reader assembly 460 which includes a smart device 470 such as a smartphone, tablet, or other computing device coupled to an RFID transceiver 480 which includes a coder/decoder for interpreting and encoding data to be sent to and from the garment.
  • the RFID transceiver 480 is also coupled to an antenna 490.
  • Computer executable instructions for implementing the disclosed technologies can be stored in computer-readable storage media located within or accessible to the smart device and/or the memory of the integrated circuit.
  • FIG. 5 illustrates a generalized example of a suitable computing environment 500 in which described embodiments, techniques, and technologies, including reporting agents and monitor servers, can be implemented.
  • the computing environment 500 can implement networked incontinence event monitoring, as described herein.
  • the computing environment 500 is not intended to suggest any limitation as to scope of use or functionality of the technology, as the technology may be implemented in diverse general-purpose or special-purpose computing environments.
  • the disclosed technology may be implemented with other computer system configurations, including hand held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, network PCs, minicomputers, mainframe computers, and the like.
  • the disclosed technology may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network.
  • program modules may be located in both local and remote memory storage devices.
  • the computing environment 500 includes at least one central processing unit 510 and memory 520.
  • the central processing unit 510 executes computer-executable instructions and may be a real or a virtual processor. In a multi-processing system, multiple processing units execute computer-executable instructions to increase processing power and as such, multiple processors can be running simultaneously.
  • the memory 520 may be volatile memory (e.g., registers, cache, RAM), non- volatile memory (e.g., ROM, EEPROM, flash memory, etc.), or some combination of the two.
  • the memory 520 stores software 580, images, and video that can, for example, implement the technologies described herein.
  • a computing environment may have additional features.
  • the computing environment 500 includes storage 540, one or more input devices 550, one or more output devices 560, and one or more communication connections 570.
  • An interconnection mechanism such as a bus, a controller, or a network, interconnects the components of the computing environment 500.
  • operating system software provides an operating environment for other software executing in the computing environment 500, and coordinates activities of the components of the computing environment 500.
  • the storage 540 may be removable or non-removable, and includes magnetic disks, magnetic tapes or cassettes, CD-ROMs, CD-RWs, DVDs, or any other medium which can be used to store information and that can be accessed within the computing environment 500.
  • the storage 540 stores instructions for the software 580 and image data, which can implement technologies described herein.
  • the input device(s) 550 may be a touch input device, such as a keyboard, keypad, mouse, touch screen display, pen, or trackball, a voice input device, a scanning device, or another device, that provides input to the computing environment 500.
  • the input device(s) 550 may be a sound card or similar device that accepts audio input in analog or digital form, or a CD-ROM reader that provides audio samples to the computing environment 500.
  • the output device(s) 560 may be a display, printer, speaker, CD-writer, or another device that provides output from the computing environment 500.
  • the communication connection(s) 570 enable communication over a communication medium (e.g. , a connecting network) to another computing entity.
  • the communication medium conveys information such as computer-executable instructions, compressed graphics information, video, or other data in a modulated data signal.
  • Some embodiments of the disclosed methods can be performed using computer- executable instructions implementing all or a portion of the disclosed technology in a computing cloud 590.
  • Computer-readable media are any available media that can be accessed within a computing environment 500.
  • computer-readable media include memory 520 and/or storage 540.
  • the term computer-readable storage media includes the media for data storage such as memory 520 and storage 540, and not transmission media such as modulated data signals.
  • the data captured and recorded by the mobile application is stored locally and via a web-based service, such as a Cloud data storage, which is accessible by facility management through a service-layer. Additionally, this data may integrate into a facility's electronic medical record (EMR) through a secure application programming interface (API). This data may be used for the creation of personalized toileting plans for residents, monitoring and identifying changes in resident incontinence patterns or behaviors, as a reporting capability for resident care decision-makers and long-term care administrators.
  • EMR electronic medical record
  • API secure application programming interface
  • the RFID tag has a custom-built antenna designed specifically for the purpose of incontinence detection.
  • the antenna is designed such that the impedance of the antenna can be altered in the presence of moisture, which can also be described as the tag being "detuned.”
  • the form of this antenna could be altered to further enhance performance such as extending the antenna to reach to the back of the brief to detect bowel movements. Future iterations could change the shape of the antenna to cover more or less distance on the brief.
  • the antenna shape could also be adapted in the case that the tag is placed on the interior of the brief. In this case, how the antenna is optimized could depend on placement, gender of the wearer, physical shape of the brief, or the absorbent materials used on the interior of the brief.
  • the tag could also be detuned or disrupted through a physical change to the antenna such as a conductive coating being used as the material for the antenna. In this case if the antenna shape is physically altered, the antenna would be detuned or disrupted. In some examples of the disclosed technology, the antenna can be physically altered in the presence of moisture.
  • the tags have been created in both copper and aluminum forms and work well.
  • Aluminum has been chosen as the optimal form because of its lower cost, however antennas made from copper or another suitable conductive material can be used. As discussed above, an antenna that is comprised of material/coating that will physically change in the presence of urine is also possible.
  • FIG. 6 illustrates two examples of antennas (610 and 620) suitable for use within an RFID assembly for placement on an incontinence garment. As shown in FIG. 6, each of the antenna designs 610 and 620 is a bi-pole design including a loop on the distal ends of the antenna. The antenna 610 on the left has been designed with larger loops 630 and 635, while the antenna 620 on the right has been designed with smaller loops 640 and 645.
  • Each of the antennas 610 and 620 is designed to be connected to an integrated circuit (650 or 655, respectively) at the lower middle portion of the antenna, thereby forming a bi-pole antenna.
  • an integrated circuit 650 or 655, respectively
  • the design of the RFID antenna can be modified to suit a particular application and adapted to various RFID reader technologies, including active and passive signaling technologies.
  • FIG. 7 is a photograph of nine different antenna designs (700-708) as can be used in certain examples of the disclosed technology. As shown in FIG. 7, testing by the inventors indicates that the designs numbered 703 and 704 are more favorable in certain implementations. However, it should be understood that any suitable antenna, including those not illustrated in FIG. 7, can be employed.
  • the tag antenna is managed by an integrated circuit located on the tag.
  • a reader sends a signal to the tag, it is the IC that answers back.
  • a more standard IC answers back to a reader typically with an identifier that has been encoded, essentially telling the remote reader what it is through the code. This is how RFID is typically used for inventory purposes.
  • the IC answers back with a reading of how hard that IC is working given how the antenna is being "detuned.”
  • This has been termed a "sensor code” which is essentially an arbitrary scale created from, for example, 1-30 that can indicate the amount of "detuning" the antenna is experiencing.
  • a sensor code of 1-14 indicates a dry brief and 15-30 indicates a wet brief.
  • a sensor code is returned to a reader, the interface on the reader is adjusted to let the caregiver know whether a wet vs dry condition exists, thus the code is translated into an action for the caregiver.
  • the amount a tag has been detuned is considered a proxy for the amount of void that has taken place.
  • a reader looks for a binary indication, however, more complex diagnostics can also be considered (e.g. , dehydration, change in urinary pattern), in which the amount of detuning could become very useful information.
  • the amount of detuning could determine the content of the urine, highlighting the condition of the individual, e.g., infection.
  • detuning to a marker that is remembered and triggered such as temperature could also be powerful information to indicate a condition of the individual.
  • FIG. 8 is a photograph 800 of a smartphone device 810 coupled to a reader 820, an RFID tag assembly 830, including adhesive backing, and a pen 840 (for scale).
  • the smartphone device 810 is shown displaying a graphical user interface, which can be used to implement applications and accessed by a caregiver to interact with an RFID tag assembly assigned on a patient's garment.
  • the smartphone device 810 has used a graphical user interface (GUI) of a software application with the reader 820 to submit a query to an RFID tag assembly attached to a garment.
  • GUI graphical user interface
  • the RFID tag assembly Responsive to detecting a moisture level using detuning methods as disclosed herein, the RFID tag assembly returns a sensor code value of ten (10), which the smartphone device in turn interprets as a dry condition.
  • the software application displays the condition as "DRY" on a green background, along with the sensor code value.
  • the smartphone application GUI also is displaying a touch screen display button labeled "Start,” which can be used to initiate the query sequence again. On the query is transmitted and a sensor code detected, the GUI will display the new sensor code value and also update the interpretation of the moisture level (e.g. , by displaying "WET” or "CHANGE"). In the event that a sensor code is not detected, the GUI can display an error message or query the user to initiate another attempt.
  • FIG. 9 is a photograph 900 illustrating a number of incontinence garments 910 that have an RFID tag assembly attached to the garments. Also shown in FIG. 9 is a smartphone device 920 in communication with an RFID tag attached to one of the garments.
  • the disclosed technology offers the potential to significantly modernize the way incontinence is managed today. It uniquely offers a disposable, inexpensive technical solution to manage the most basic of human needs. It can offer a massive increase in quality of care/dignity to individuals, assist caregivers manage a difficult condition, and offer cost savings/risk mitigation to LTC facilities.
  • Facilities would be able to routinely monitor, assess and record incontinence events (chart) without wasting briefs or caregiver time. More importantly, facilities would be able to reduce, or even potentially eliminate care costs related to incontinence-related injuries. As health care reforms continue to push accountability for cost to providers, the savings potential, and risk reduction for facilities is enormous.
  • an RFID integrated circuit is configured to keep a tag functional when near moisture (e.g. , when the impedance of the antenna is altered).
  • the RFID integrated circuit detects when the RFID integrated circuit is attempting to retune itself, e.g. , when the IC is adjusting its receiving antenna impedance to maintain a reading, thereby indicating the presence of moisture.
  • the RFID reader sends a signal to the passive RFID tag, the response given from the tag enables the reader to tell whether that tag is in the presence of moisture or not, thus whether the brief is wet or dry.
  • a RFMicron technology Magnus® S family of products provides a passive, wireless, single-chip sensor solution that can be used to implement disclosed methods and apparatus.
  • an integrated circuit automatically adjusts the input impedance of the IC to optimally tune the tag to varying frequencies and environmental conditions.
  • a self-tuning circuit produces a 5-bit sensor code using a standard Electronic Product Code (EPC) Gen2 READ command.
  • EPC Electronic Product Code
  • the sensor code provides a direct measure of the antenna's impedance. Based on the chosen antenna design and the effect of the environment on the impedance, changes in the sensor code indicate a change in the environment.
  • On-chip Received Signal Strength Indication which indicates the strength of the signal sent from the sensor to an RFID reader, can also be employed by an integrated circuit in some examples of the disclosed technology.
  • the On-Chip RSSI is a 5-bit digital output that can be read by the reader using standard EPC Gen2 commands and can be used as a data resource providing a direct measurement of the signal strength seen by the tag. This feature is useful in development, characterization, and system installation to manage the response of large tag deployments.
  • the sensor code reading indicating the amount of detuning, and the RSSI signal strength indication can be combined to generate a more accurate measurement of the amount of moisture in the garment.
  • electromagnetic signals having frequencies in the range of 860-960 MHz are used to transmit signals between an incontinence garment and a reader.
  • a dipole antenna is implemented with a passive UHF inlay equipped with an RFID tag integrated circuit.
  • the sensor inlay offers great performance, and accurately detects and measures moisture levels in the surrounding environment.
  • aggregate data monitoring can provide useful management tools.
  • Billing of incontinence supplies to each resident can become automated and enable for one inventory supply rather than inventory held for each resident.
  • Legal protection/ risk mitigation, and quality metrics are possible by accurate charting of incontinence brief changes.
  • the data collected also enables caregiver oversight to ensure care protocols are implemented. Correlation of change frequency with health outcomes (e.g. , UTIs, skin breakdowns, pressure ulcers) can be monitored.
  • an additional alert is generated if a new garment is not installed within a predetermined period of time (e.g. , 30 minutes).
  • a predetermined period of time e.g. , 30 minutes.
  • there is an additional layer of reporting for the supervisor or customer e.g. , Medicare agency, family of patient.
  • an absence of readings is reported after a specified period of time to remind the caregiver to go stand next to the patient (and request a reading).
  • a quality of care metric is generated and reported to management in lieu of the raw data.
  • a plurality of readings is averaged and/or thresholded to reduce false positives.
  • FIG. 10 is a flowchart 1000 illustrating an example method of reading data from a sensor coupled to a garment, for example an incontinence garment.
  • a sensor coupled to a garment
  • the example RFID assemblies and mobile devices discussed above can be used to implement the method of FIG. 10.
  • the data can include information associating a patient with particular RFID tag identifiers, or associating one or more caregivers with the resident patient.
  • a sensor integrated with a garment worn by the resident patient is read.
  • a mobile device coupled to an RFID reader, or an RFID reader embedded in a mobile device itself can send an RF signal to an integrated circuit electrically connected to an antenna.
  • the integrated circuit determines fluctuations in the signal received, calculates the amount of detuning observed at the patient (e.g., due to changes in moisture levels near the antenna), and returns a signal indicating the amount of detuning observed.
  • a mobile software application being executed by a processor of the mobile device processes the sensor data produced at process block 1020.
  • the mobile software application can use the data to make a recommendation on whether or not to change a garment worn by the resident patient.
  • FIG. 11 is a flowchart 1100 outlining an example method of evaluating sensor condition data, as can be performed in certain examples of the disclosed technology.
  • the mobile devices and RFID tag assemblies discussed above can be used to implement the method of FIG. 11.
  • patient and caregiver data is received.
  • the data can indicate an association between a patient and one or more RFID sensors, and/or an association between a caregiver and locations in a care facility or associations between the caregiver and the patient.
  • the caregiver initiates data acquisition using a mobile device.
  • mobile device can use a graphical user interface to display controls that are actuated by the caregiver to initiate data acquisition.
  • the caregiver can initiate data acquisition when they are within close proximity to the patient.
  • data acquisition response data is received by the mobile device.
  • the mobile device at process block 1120 can send a radio signal that is received by an integrated circuit coupled to a sensor on a garment worn by the patient.
  • the RFID assembly can be positioned such that increased levels of moisture detune the signal received from the mobile device.
  • the integrated circuit determines a moisture level that is encoded as a variable value that is transmitted back to the mobile device. For example, the amount of moisture can be indicated on a scale of 0-30, 0-100, or another suitable range of values.
  • the mobile device evaluates the sensor condition based on the received data. If the sensor condition indicates that action should be taken with respect to the patient, then the method proceeds to process block 1150. If the sensor condition indicates that no action is needed with respect to the patient at the current time, then the method proceeds to process block 1160. If the sensor condition indicates that there was a problem acquiring data from the sensor, then the method proceeds to process block 1170.
  • the caregiver changes the garment worn by the user, and then uses controls associated with a mobile device to associate a new RFID tag of a new garment worn by the user with records in the computer database associated with the patient. After the resident has been changed and records for the sensor updated, the method proceeds to process block 1160.
  • sensor data is recorded and notes entered by the caregiver can optionally be stored along with the patient data. For example, information regarding whether the patient was awake or not, their general condition, and other data can be stored in the database. Further, other data such as time of day and caregiver location can be recorded at the same time.
  • the method proceeds to process block 1120, whether the caregiver can initiate data acquisition at a later point in time. Some example data acquisition is initiated by statically placed sensors in a care facility. Thus, as a patient comes into close proximity with the sensors, the data from the patient's garment can be acquired automatically.
  • FIG. 12 is a table 1200 outlining data that can be output using certain examples of the disclosed technology.
  • a number of data fields are acquired and can be used to determine incontinence events and added to a patient's electronic chart. These fields include data and time that an incontinence sensor was read, name of the caregiver performing the reading, the patient' s name, a result expressed as a string (e.g. , "Wet" or "Dry"), a numeric value representing a moisture level, notes entered by the caregiver, and a time for sending a reminder to re-check moisture level of the garment using the RFID reader assembly.
  • a string e.g. , "Wet" or "Dry
  • a caregiver places an RFID tag on the exterior of a resident's incontinence brief (adult diaper) when assisting with changing and dressing.
  • a brief from any manufacturer is suitable.
  • the caregiver cues the reader to search for a tag by pressing a start "button" displayed with a graphical user interface of the reader. Responsive to the start button being pressed, the reader sends an RF signal from its antenna to search for the RFID tag.
  • the RFID tag (passively or actively) bounces back a reading indicating that it has been found and a signal measurement indicating the amount of detuning the tag antenna is experiencing.
  • Software on the reader averages the return signals to eliminate outlier data and interprets the signal measurement and indicates action to be performed by the caregiver (e.g. , wet/change resident or dry/do not disturb resident). If no reading can be detected the software will prompt the caregiver to change position (e.g., Move closer or change angle) and retry by pressing start "button" again. If still no reading is found, the software will prompt the caregiver to conduct a manual check.
  • a caregiver places the RFID tag on the exterior of a resident's incontinence brief (adult diaper) when assisting with changing and dressing.
  • the caregiver uses the software interface on the mobile reader to record that the resident has been changed and a new tag employed. After a predefined elapsed time, the caregiver moves within proximity of resident to be monitored.
  • the caregiver uses the software interface to indicate that a check is being made on a particular resident.
  • the caregiver cues the reader to search for a tag by pressing a start "button.”
  • the reader sends a signal from its antenna to search for the RFID tag.
  • the tag returns a signal encoding a reading indicating that it has been found and a signal measurement indicating the amount of detuning the tag antenna is experiencing.
  • Software on the reader interprets the signal measurement and indicates the action to be performed by the caregiver (e.g. , wet/change resident or dry/do not disturb resident).
  • the reader software records (charts) the check made for a resident and the resulting signal measurement. If no reading is detected the graphical user interface is used to prompt the caregiver to change position (e.g. , move closer or change angle) and retry by pressing start "button" again. If still no reading is found, the graphical user interface prompts the caregiver to conduct a manual check.
  • a caregiver place the RFID tag on the exterior of a resident's incontinence brief (adult diaper) when assisting with changing and dressing.
  • the caregiver couples his/her smart device (phone, tablet, etc.) of any form (e.g., iPhone or android) with a specialized RFID reader.
  • the smart device includes built-in RFID reader functionality.
  • the caregiver uses an application on the smart device to record that the resident has been changed and new tag employed. After a predefined elapsed time period, the caregiver moves within proximity of resident to be monitored.
  • the caregiver uses the smart device application and reader to indicate that a check is being made on a particular resident.
  • the caregiver cues the smart device application to search for a tag by pressing a start "button" on the reader, which sends an RF signal from its antenna to search for the RFID tag.
  • the RFID tag returns a signal indicating that it has been found and a signal measurement indicating the amount of detuning the tag antenna is experiencing.
  • the smart device application analyzes the signal measurement and indicates an action to be performed by the caregiver (e.g., wet/change resident or dry/do not disturb resident).
  • the smart device application records (charts) the check made for a resident, and the resulting signal measurement. If no reading is detected, the software prompts the caregiver to change position (e.g., move closer or change angle) and retry by pressing start "button" again.
  • a caregiver supervisor allocates uniquely identified tags (EPC code) to a resident and registers the EPC code with the software interface on the reader.
  • the caregiver places the uniquely identified RFID tag on the exterior of a resident's incontinence brief (adult diaper) when, for example, assisting with changing and dressing.
  • the caregiver performs an initial reading of the tag using a smart device reader as described above regarding Examples two or three, such that the smart device reads that a tag is in use. After an elapsed time, the caregiver moves within proximity of resident to be monitored.
  • the caregiver cues the reader to search for a tag by pressing a start "button.”
  • the reader sends an RF signal from its antenna to search for the RFID tag.
  • the tag returns a reading indicating that it has been found, its unique EPC code, and a signal measurement indicating the amount of detuning the tag antenna detected.
  • the smart device determines the resident that is being checked, the signal measurement, and indicates the action required by the caregiver (e.g. , wet/change resident or dry/do not disturb resident).
  • the software records (charts) the check made for a resident, and the resulting signal measurement. If no reading can be detected the software prompts the caregiver to change position (e.g. , move closer or change angle) and retry by pressing start "button" again. If still no reading is found, the software prompts the caregiver to conduct a manual check.
  • a caregiver places the RFID tag on the exterior of a resident's incontinence brief (adult diaper) when assisting with changing and dressing.
  • the caregiver registers that the RFID tag is newly in use at a central nursing station location.
  • the caregiving facility is equipped with fixed RFID readers placed and aimed at key places for the residents (e.g. , doorways, beds, commonly used chairs).
  • the fixed readers periodically (e.g. , every 1 minute) transmit an RFID signal to search for tags and their status.
  • the RFID tag returns a reading indicating that it has been found and a signal measurement indicating the amount of detuning the tag antenna is experiencing.
  • Software instructions executed by the reader interprets the signal measurement and notifies caregivers when a change is needed through the nursing station and/or a pager.
  • the software records (charts) the checks made for a resident, and the resulting signal measurement.
  • the tags can be uniquely EPC coded so that the staff knows which resident needs a change or indicates the location of the resident so that the caregiver can then determine which resident has been detected. If still no changes have been made for a particular resident after a certain elapsed time, the software will prompt the caregiver to conduct a manual check and/or make a change.
  • an RFID tag is printed directly onto an incontinence brief (adult brief) or is built into the interior of a brief.
  • each brief can be uniquely identified and pre-assigned to a resident.
  • the caregiver uses the software interface on the mobile reader to record that the resident has been changed and a new tag enabled brief employed. After an elapsed time, the caregiver moves within proximity of resident to be monitored.
  • the caregiver uses the software interface to indicate that a check is being made on a particular resident.
  • the caregiver cues the reader to search for a tag by pressing a start "button" with a graphical user interface of a mobile device.
  • the mobile device reader sends a signal from its antenna to search for the RFID tag.
  • the tag returns a reading indicating that it has been found and a signal measurement indicating the amount of detuning the tag antenna observed.
  • Software executing on the reader interprets the signal measurement and indicates the action required by the caregiver (e.g., wet/change resident or dry/do not disturb resident).
  • the software records (charts) the check made for a resident, and the resulting signal measurement. If no reading is detected the device will prompt the caregiver to change position (e.g. , move closer or change angle) and retry by pressing start "button" again. If still no reading is found, the device prompts the caregiver to conduct a manual check.

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Abstract

L'invention concerne des procédés et appareils pour surveiller des événements d'incontinence au moyen de capteurs peu couteux couplés à une culotte d'incontinence portée par un patient. Dans certains exemples de la technologie selon l'invention, une étiquette d'identification par radiofréquence (RFID) est interrogée pour renvoyer une valeur de capteur indiquant un niveau d'humidité dans une culotte d'incontinence. Un dispositif mobile porté par un soignant du patient analyse la valeur du capteur et affiche une indication de plan d'action, par exemple, la nécessité ou non de changer la culotte d'incontinence du patient.
PCT/US2016/033590 2015-05-21 2016-05-20 Surveillance d'événements d'incontinence WO2016187568A1 (fr)

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